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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US MBT REVISION REAMER 13MM; KNEE INSTRUMENT : REAMERS
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DEPUY ORTHOPAEDICS INC US MBT REVISION REAMER 13MM; KNEE INSTRUMENT : REAMERS Back to Search Results
Catalog Number 217863173
Medical Device Problem Code Material Deformation (2976)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 11/26/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event or Problem Description
It was reported that the top of the reamers were rounded out and would not stay locked in the hudson adapter.
 
Additional Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
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Brand Name
MBT REVISION REAMER 13MM
Common Device Name
KNEE INSTRUMENT : REAMERS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key8124070
Report Number1818910-2018-76896
Device Sequence Number2166021
Product Code HTO
UDI-Device Identifier10603295096306
UDI-Public10603295096306
Combination Product (Y/N)N
Initial Reporter StateSC
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 11/26/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Catalogue Number217863173
Device Lot NumberNG30970
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/18/2018
Initial Date Received by Manufacturer 11/26/2018
Supplement Date Received by Manufacturer12/20/2018
Initial Report FDA Received Date12/03/2018
Supplement Report FDA Received Date12/26/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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